NCT05916456

Brief Summary

Hand10 questionnaire, Boston Carpal Tunnel Syndrome Questionnaire and Arm Shoulder Questionnaire for patients with carpal tunnel syndrome and Hand Deficiencies Questionnaire (DASH) will be applied one week apart to investigate the validity of the questionnaire. Test-retest reliability and internal consistency will be determined using Intraclass Correlation Coefficient analysis and Cronbach alpha, respectively. The validity of Hand10 in individuals with CST will be determined using the Pearson Correlation Coefficient analysis, the Arm, Shoulder, and Hand Disability Questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 27, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

June 7, 2023

Last Update Submit

December 24, 2024

Conditions

Keywords

carpal tunnel syndromeDASH questionnaireBoston carpal tunnel syndrome questionnaireHAND10 questionnairevalidity and reliability

Outcome Measures

Primary Outcomes (1)

  • The validity and reliability of the Hand10 questionnaire to individuals with carpal tunnel scan included

    Patients diagnosed with Carpal tunnel by the doctor

    3 month

Interventions

The Hand10 Questionnaire is a questionnaire consisting of 10 short questions used in the evaluation of upper extremity diseases. These questions are easy to understand and illustrated questions. Unlike other questionnaires, thanks to these features, it can be used in adults as well as in the elderly and children. Tore et al. In their study, the internal consistency of Hand10 was evaluated with Cronbach's alpha value according to statistical results and found it to be 0.919. According to these results, it has been determined that Hand10 is a reliable and valid assessment tool for patients with upper extremity disorders in the Turkish population.

DASH QuestionnaireDIAGNOSTIC_TEST

DASH Questionnaire is one of the widely used questionnaires consisting of 30 items. There are five options for each answer. While getting answers ranging from 1 to 5; 1 means no symptoms and 5 means very severe symptoms. The total DASH score ranges from 0 to 100; 0 means no injury and 100 means serious injury. Contrary to the Hand10 questionnaire, DASH was not suitable for assessing upper extremity disorders in patients over 65 years of age.

Boston carpal tunnel syndrome questionnaire (BKTSA) will be used to evaluate the functionality level and symptom severity of the patients. In this questionnaire, which consists of 2 parts: symptom severity and functional capacity, the average score for each part will be calculated by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our study will be conducted with individuals between the ages of 18-70 who have been diagnosed with CTS.

You may qualify if:

  • Patients who volunteer for treatment
  • years old patients
  • With patients diagnosed with CTS

You may not qualify if:

  • Patients who have had surgery on the wrist area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Universty

Gaziantep, Sahinbey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 23, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2023

Study Completion

June 1, 2025

Last Updated

December 27, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations